Biomedical Development Corporation

OUR RESEARCH

Research generated by BDC is often presented at recognized national and international scientific meetings and published in peer-reviewed journals. Partnering with academia and publishing are considered fundamental to our mission.

A novel iodine-based oral rinse is being developed as a once-daily treatment for gingivitis. The oral rinse has demonstrated broad-spectrum antimicrobial, antifungal and antiviral activity in vitro, and safety in animal and human clinical trials. Ongoing clinical studies continue to assess its safety, efficacy and potential impact on biomarkers of inflammation.

OBJECTIVE

The purpose of this study was to evaluate a novel iodine-based oral rinse for safety and for use in reducing gingivitis and biological markers of inflammation in otherwise healthy human subjects.

METHODS

All subjects received dental prophylaxis at the beginning of the study. Study participants were randomized to receive either a placebo rinse or a once-daily, 30 second iodine-based oral rinse. Subjects were evaluated four times over a three month period and dental assessment indices for gingivitis, plaque, and bleeding scores were collected. Blood tests were performed to assess safety and to determine the effects of the oral rinse on relative levels of biological markers of inflammation and low-density lipoprotein cholesterol (LDL-C). Statistical analysis was performed using the Student's t-test and the nonparametric Mann-Whitney U-test.

No treatment-related adverse events were observed. Results showed that after three months of treatment, LDL-C in the iodine-based oral rinse treatment group was significantly (pCONCLUSIONS

The novel iodine-based oral rinse was shown to be safe in the study. The use of this iodine-based oral rinse may be associated with lower LDL-C. Additional studies are needed to further define the efficacy of the once-daily iodine rinse and evaluate its effect on biological markers of inflammation.

FUTURE DIRECTION

A new 6-month placebo controlled trial (n= 76) is underway at the Center for Oral Health Research at The University of Kentucky. Study endpoints include safety, efficacy against gingivitis, and impact on biomarkers of inflammation including: a full lipid panel, endotoxin, interleukin-1 beta, interleukin-6, C-reactive protein, acute phase proteins and cardiovascular disease analytes, prostaglandin E2 and isoprostane.

Cholesterol – LDL-C
No signicant dierences in LDL-C
between placebo and treatment group
at baseline
LDL-C signicantly (p<0.05) lower in
treatment group vs. placebo at day 90
ACKNOWLEDGEMENTS

The project described was supported by Grant Number 5R44HL101821 from the National Heart, Lung, and Blood Institute. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Heart, Lung, and Blood Institute. This technology was supported in part by an award from the Kentucky Cabinet for Economic Development, Office of Commercialization and Innovation, under the Grant Agreement KSTC-184-512-12-145 with the Kentucky Science and Technology Corporation